EUROLAB
iso-13485-quality-management-systems-for-medical-devices
Biocompatibility Testing ASTM F1609 Evaluation of Surface ContaminationASTM F1904 Protein Adsorption TestingASTM F1980 Accelerated Aging of Medical DevicesASTM F2027 Cytotoxicity EvaluationASTM F2028 Evaluation of Sterilization ResidualsASTM F2052 Magnetically Induced DisplacementASTM F2080 Durability TestingASTM F2095 Evaluation of Additives in Medical PolymersASTM F2096 Particulate TestingASTM F2100 Medical Mask TestingASTM F2130 Endotoxin TestingASTM F2149 Antimicrobial Activity TestingASTM F2180 Sterilization Validation for HydrogelsASTM F2182 RF Induced Heating TestsASTM F2213 Evaluation of Magnetic Resonance CompatibilityASTM F2255 Acute Systemic ToxicityASTM F2273 Cytokine AnalysisASTM F2392 Implant Wear Debris AnalysisASTM F2458 Biofilm Formation TestingASTM F2459 Adhesion of Medical Device CoatingsASTM F2478 Safety Evaluation of PolymersASTM F2503 MR Safety LabelingASTM F2900 Testing of BiopolymersASTM F2941 Shelf Life TestingASTM F640 Extraction of Medical DevicesASTM F748 Evaluation of Medical Device BiocompatibilityASTM F756 Assessment of Hemolytic PropertiesEN ISO 10993-1 Biological Evaluation – Part 1EN ISO 10993-10 Sensitization TestingEN ISO 10993-11 Systemic ToxicityEN ISO 10993-5 Cytotoxicity TestingIEC 60601-1 Safety Requirements for Medical Electrical EquipmentISO 10993-1 Biological Evaluation of Medical DevicesISO 10993-10 Sensitization TestingISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation and Reference MaterialsISO 10993-13 Identification and Quantification of Degradation ProductsISO 10993-14 Degradation TestingISO 10993-15 Toxicokinetic StudyISO 10993-16 Toxicokinetic Study ProtocolISO 10993-17 Establishing Allowable LimitsISO 10993-18 Chemical Characterization TechniquesISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 10993-23 Biological Evaluation of ResidualsISO 10993-24 Toxicological Risk AssessmentISO 10993-25 Genotoxicity in Medical DevicesISO 10993-26 Immunotoxicology TestingISO 10993-27 Implant Material CharacterizationISO 10993-28 Evaluation of Metallic ImplantsISO 10993-29 Extraction ConditionsISO 10993-3 Genotoxicity TestingISO 10993-30 Analytical TechniquesISO 10993-31 Mutagenicity TestingISO 10993-32 Toxicity Tests for Medical PolymersISO 10993-33 Biological Evaluation of Degradation ProductsISO 10993-34 Evaluation of Chemical ResiduesISO 10993-35 Assessment of Extractables and LeachablesISO 10993-36 Nonclinical Safety EvaluationISO 10993-37 Evaluation of Cytokine ReleaseISO 10993-38 Endocrine Disruption TestingISO 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 10993-40 Evaluation of HemocompatibilityISO 10993-41 Toxicological Risk Assessment FrameworkISO 10993-42 Assessment of NanomaterialsISO 10993-5 Cytotoxicity TestingISO 10993-6 Local Effects after ImplantationISO 10993-7 Ethylene Oxide ResidualsISO 10993-9 Chemical CharacterizationISO 11135 Ethylene Oxide SterilizationISO 11137 Radiation SterilizationISO 11607 Packaging for Terminally Sterilized DevicesISO 11607-1 Packaging ValidationISO 11607-2 Packaging MaterialsISO 11607-3 Packaging TestingISO 11737-1 Sterilization ValidationISO 11737-2 Microbial Limit TestsISO 11737-3 Bioburden DeterminationISO 13408 Aseptic ProcessingISO 13408-1 Cleanroom TestingISO 13408-2 Aseptic Processing ValidationISO 13485 Risk Management IntegrationISO 13485-1 Quality System RequirementsISO 14117 Pulse Oximeter PerformanceISO 14155 Clinical Investigation StandardsISO 14155-1 Clinical Trial DesignISO 14155-2 Clinical Trial ConductISO 14160 Biocompatibility for Transfusion EquipmentISO 14161 Sterilization by Ethylene OxideISO 14161 Validation of Sterilization ProcessesISO 14630 Non-active Surgical ImplantsISO 14644 Cleanroom StandardsISO 14708 Active Implantable Medical DevicesISO 14708-3 Active Implantable Device TestingISO 14708-4 Implantable Device SafetyISO 14969 Quality Management for Sterile DevicesISO 14971 Risk Management DocumentationISO 14971 Risk Management for Medical DevicesISO 14971-2 Risk Management ReportingISO 15223 Medical Device SymbolsISO 17025 Testing Laboratory AccreditationISO 18113 Medical Device LabelingISO 18562 Biocompatibility of Breathing Gas PathwaysISO 22442 Medical Device Material TestingISO 25539 Cardiovascular ImplantsISO 25539-2 Coronary StentsISO 7405 Evaluation of Biocompatibility for DentistryISO 80369 Small-Bore ConnectorsUSP <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

ISO 13485 Quality Management Systems for Medical Devices Laboratory Testing Service

Eurolabs Expertise in Ensuring Product Safety and Compliance

The ISO 13485 standard is a quality management system (QMS) specifically designed for medical devices. It ensures that medical devices are designed, developed, produced, and delivered according to the requirements of both national and international regulations.

ISO 13485 is based on the principles of ISO 9001, which is a more general QMS standard applicable to various industries. However, ISO 13485 has specific requirements tailored to meet the unique needs of medical devices, including design and development controls, production and service provision controls, and post-delivery activities.

The standard applies to organizations involved in one or more stages of the life cycle of a medical device, including:

  • Design and development

  • Production

  • Installation

  • Servicing

  • Maintenance

    • ISO 13485 requires that organizations implement a QMS that includes processes for risk management, design and development controls, production and service provision controls, post-delivery activities, and corrective action.

    In addition to ISO 13485, several other international standards are relevant to medical devices laboratory testing services. These include:

  • ISO/TS 13487:2012 - Medical devices Quality management systems Requirements for regulatory purposes

  • IEC 60601-1:2008 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance

  • ASTM F738-14 Standard Specification for Surgical Staples

    • European Union (EU) Regulations

    The EU has implemented a series of regulations governing medical devices, including:

  • Directive 93/42/EEC on the approximation of laws of Member States relating to medical devices (MDD)

  • Directive 2007/47/EC amending Directive 2001/83/EC as regards principles of good laboratory practice and the accreditation of test laboratories

  • Regulation (EU) 2017/745 on medical devices

    • These regulations require that medical devices comply with specific requirements, including design and development controls, production controls, and post-market surveillance.

    Industry-Specific Standards

    Several industry-specific standards are relevant to medical devices laboratory testing services. These include:

  • ASTM F1231-08 Standard Specification for Surgical Drains

  • ISO 10993-1:2018 - Biological evaluation of medical devices Part 1: Evaluation of biological properties in vitro

    • Evolution and Updates

    Standards evolve over time to reflect changing regulatory requirements, technological advancements, and industry practices. Organizations must stay up-to-date with the latest standards and updates to ensure compliance.

    Eurolab stays current with the latest developments by participating in relevant standard development organizations (SDOs), attending conferences, and engaging with industry experts.

    Standard Compliance Requirements

    Compliance with ISO 13485 requires that organizations implement a QMS that meets specific requirements. These include:

  • Document control

  • Design and development controls

  • Production and service provision controls

  • Post-delivery activities

  • Corrective action

    • Non-compliance can result in serious consequences, including fines, penalties, and damage to reputation.

    ISO 13485 is essential for medical devices laboratory testing services because it ensures that products meet the required safety and performance standards. Non-compliance with ISO 13485 can result in serious consequences, including:

  • Injuries or deaths due to defective products

  • Financial losses due to recalls, fines, and penalties

  • Damage to reputation and loss of customer trust

    • The business and technical reasons for conducting ISO 13485 testing include:

  • Ensuring product safety and performance

  • Meeting regulatory requirements

  • Reducing the risk of non-compliance and associated consequences

  • Improving quality and reducing costs through efficient processes

  • Enhancing customer satisfaction and trust

    • Consequences of Not Performing This Test

    Not performing this test can result in serious consequences, including:

  • Non-compliance with regulatory requirements

  • Injuries or deaths due to defective products

  • Financial losses due to recalls, fines, and penalties

  • Damage to reputation and loss of customer trust

    • The industries and sectors that require ISO 13485 testing include medical device manufacturers, healthcare providers, and regulatory authorities.

    Risk Factors and Safety Implications

    ISO 13485 testing is essential for identifying and mitigating risk factors associated with medical devices. The safety implications of non-compliance are severe, including injuries or deaths due to defective products.

    Quality Assurance and Quality Control Aspects

    ISO 13485 ensures that organizations implement a QMS that includes processes for quality assurance (QA) and quality control (QC). QA ensures that the organization meets regulatory requirements, while QC ensures that products meet required safety and performance standards.

    The test conditions and methodology for ISO 13485 testing include:

  • Design and development controls

  • Production and service provision controls

  • Post-delivery activities

  • Corrective action

    • Eurolabs expert technicians conduct tests in accordance with established protocols to ensure accurate and reliable results.

    Sample Preparation

    Before conducting tests, Eurolab prepares samples according to specific requirements. This includes:

  • Sample collection

  • Storage and handling

  • Sample preparation

    • Testing Procedures

    Eurolab conducts testing procedures according to established protocols, including:

  • Instrument calibration and validation

  • Test execution

  • Data analysis and reporting

    • Documentation and Record-Keeping

    Eurolab maintains comprehensive documentation and records of all test results, including:

  • Test reports

  • Certificates of conformity

  • Calibration records

  • Maintenance records

    • This ensures that organizations can track changes, updates, and revisions to the testing process.

    Conclusion

    ISO 13485 is a critical standard for medical devices laboratory testing services. It ensures that products meet required safety and performance standards while minimizing risk factors associated with non-compliance. Eurolabs expert technicians are committed to ensuring compliance with this standard through accurate and reliable testing procedures.

    Eurolabs Expertise in ISO 13485 Testing

    Eurolab is a leading provider of medical devices laboratory testing services, including:

  • Design and development controls

  • Production and service provision controls

  • Post-delivery activities

  • Corrective action

    • Our expert technicians are certified to conduct tests according to established protocols. We maintain comprehensive documentation and records of all test results.

    Contact Us

    For more information about ISO 13485 testing services, please contact Eurolab at insert contact information.

    References

    1. ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes

    2. Directive 93/42/EEC on the approximation of laws of Member States relating to medical devices (MDD)

    3. Regulation (EU) 2017/745 on medical devices

    Glossary

  • Design and development controls: The processes used to ensure that products meet required safety and performance standards.

  • Production and service provision controls: The processes used to ensure that products are manufactured according to established protocols.

  • Post-delivery activities: The processes used to monitor and evaluate product performance after delivery.

    • Appendix

    1. ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes

    2. Directive 93/42/EEC on the approximation of laws of Member States relating to medical devices (MDD)

    3. Regulation (EU) 2017/745 on medical devices

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